HeartWare International, Inc. (HeartWare), announced that HeartWare has surpassed 50 implants in the United States under its ADVANCE Clinical Trial, marking an important early enrollment milestone.
The 50th implant in the US was performed at the Texas Heart Institute in Houston, Texas by O.H. Frazier, MD a distinguished surgeon, scientist, and academician renowned for his research and development of new cardiovascular surgical techniques and ventricular assist devices. “We are very pleased with the early clinical results of this small pump. Its unique inflow cannula and small size enable us to place the device without a surgical pump pocket, which greatly reduces the risk of serious infection. The improved pump simplifies implantation and allows for optimal function, even in difficult cases where the myocardium is thin or the apex of the ventricle is difficult to access,” said Dr. Frazier.
HeartWare’s ADVANCE Clinical Trial is an FDA approved IDE study designed to evaluate the HeartWare Ventricular Assist system as a bridge to heart transplantation for patients with end stage heart failure. The primary endpoint of the trial is survival at 180-days post surgical implantation. Under the IDE, a total of 150 patients will be enrolled across a maximum of 28 centers. Currently, 16 centers are enrolling patients. HeartWare expects the number of active centers to expand steadily over coming months as the balance of the 28 sites work through the steps required to begin enrolling patients.